510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EMRClass I

File, Periodontic

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

EMR is the FDA product code for File, Periodontic, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
EMR
Device name
File, Periodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code EMR

By decision year
1 clearance under product code EMR with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EMR by decision year
YearClearances
19831

Applicants with the most clearances

Product code EMR
Applicants holding the most 510(k) clearances under product code EMR
ApplicantClearances
North Pacific Dental, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 57 companies shown, in name order